Browsing by Author "Targonski, Paul V."

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    Alanyl-glutamine Supplementation for Clostridioides difficile Infection Treatment (ACT): A double-blind randomized controlled trial
    Warren, Cirle A.; Shin, Jae Hyun; Bansal, Ekta N.; Costa, Deiziane V. D. S.; Wang, Xin Qun; Wu, Martin; Swann, Jonathan R.; Behm, Brian W.; Targonski, Paul V.; Archbald-Pannone, Laurie (BMJ Journals, 2023-07-19)
    Introduction: Clostridioides difficile is the leading cause of healthcare-associated infections in the USA, with an estimated 1 billion dollars in excess cost to the healthcare system annually. C. difficile infection (CDI) has high recurrence rate, up to 25% after first episode and up to 60% for succeeding episodes. Preliminary in vitro and in vivo studies indicate that alanyl-glutamine (AQ) may be beneficial in treating CDI by its effect on restoring intestinal integrity in the epithelial barrier, ameliorating inflammation and decreasing relapse. Methods and analysis: This study is a randomised, placebo-controlled, double-blind, phase II clinical trial. The trial is designed to determine optimal dose and safety of oral AQ at 4, 24 and 44 g doses administered daily for 10 days concurrent with standard treatment of non-severe or severe uncomplicated CDI in persons age 18 and older. The primary outcome of interest is CDI recurrence during 60 days post-treatment follow-up, with the secondary outcome of mortality during 60 days post-treatment follow-up. Exploratory analysis will be done to determine the impact of AQ supplementation on intestinal and systemic inflammation, as well as intestinal microbial and metabolic profiles. Ethics and dissemination: The study has received University of Virginia Institutional Review Board approval (HSR200046, Protocol v9, April 2023). Findings will be disseminated via conference presentations, lectures and peer-reviewed publications. Trial registration number NCT04305769.